510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GFSClass II

Standards And Controls, Hemoglobin, Normal And Abnormal

21 CFR 864.8625 / Hematology
FDA source (opens on fda.gov)

GFS is the FDA product code for Standards And Controls, Hemoglobin, Normal And Abnormal, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GFS
Device name
Standards And Controls, Hemoglobin, Normal And Abnormal
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code GFS

By decision year
1 clearance under product code GFS with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GFS by decision year
YearClearances
20021

Applicants with the most clearances

Product code GFS
Applicants holding the most 510(k) clearances under product code GFS
ApplicantClearances
Bioresource Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code